CurrentPremera BluecrossPolicy N/A

PHARMACOLOGIC TREATMENT OF GOUT

Defines medical necessity criteria, site-of-service review rules, documentation, coding, and length of approval for specified gout pharmacologic therapies (Ilaris/canakinumab, Krystexxa/pegloticase, brand colchicine, febuxostat, allopurinol) for Premera members. Applies to medical and pharmacy benefits as specified and includes age-based site-of-service review thresholds.

Policy Summary

PayerPremera Bluecross

PolicyPHARMACOLOGIC TREATMENT OF GOUT

Policy CodePolicy N/A

Change TypeRemoved Mitigare; added/updated Ilaris, Krystexxa, Colcrys criteria

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical evaluation, G6PD status, and medication history to demonstrate medical necessity.

POLICY UPDATE CHANGES

Removed coverage criteria for Mitigare (colchicine).

Added site of service review to Ilaris (canakinumab).

Added coverage criteria for Ilaris (canakinumab) for treatment of acute gout flares.

Added requirement that Krystexxa be co-administered with oral methotrexate 15 mg weekly unless contraindicated.

Added Colcrys (colchicine) to list of drugs requiring prior trial of generic oral colchicine or generic oral allopurinol.

Moved several gout drugs from a different policy into this policy with no coverage changes.

3Drugs with detailed medical necessity criteria (Ilaris, Krystexxa, brand colchicine family)

6Key clinical conditions listed for hospital-based SOS

2Age thresholds (18 for Ilaris, 13 for SOS review)

Coverage Summary

This policy (effective March 1, 2026; last reviewed February 23, 2026) defines medical necessity criteria and site-of-service review rules for selected gout therapies with a mixed coverage stance. It highlights key laboratory thresholds: serum uric acid (sUA) levels above 6.8 mg/dL predispose to monosodium urate crystal formation, and a treatment response target is sUA 6 mg/dL (used as an inadequate response threshold and as a re-authorization/continued response marker).

Quick reference thresholds

Serum uric acid (thresholds)> 6 mg/dL for inadequate response; target < 6 mg/dL for continued response

Age for Ilaris (canakinumab) acute gout coverage>= 18 years

Age for Site-of-Service (SOS) review>= 13 years

Krystexxa (pegloticase) dosing frequency8 mg IV every 2 weeks

Ilaris dosing limit150 mg every 12 weeks

Medical Necessity Criteria (detailed trees)

Site of Service Medical Necessity Criteria

Site of Service (SOS) Medical Necessity criteria applies to medical benefit reviews and to IV/injectable drugs; applies to ages >=13 for SOS review. SOS does NOT apply to Alaska fully-insured members.

ALL of the following

SOS applies: Site of Service (SOS) Medical Necessity criteria applies ONLY to medical benefit reviews and does NOT apply to Alaska fully-insured members; applies to all other plan members
Age for SOS review: For site-of-service review, individual is aged 13 years or older>= 13 years
IV/injectable drugs included: We will review specific intravenous (IV) and injectable drugs for medical necessity for all ages; SOS review applies to listed injectable/IV drugs (e.g., Ilaris) for individuals >=13 when SOS review is required

Coding

HCPCS - Ilaris (canakinumab)HCPCSCovered

J0638

Injection, canakinumab (Ilaris), 1 mg

HCPCS - Krystexxa (pegloticase)HCPCSCovered

J2507

Injection, pegloticase (Krystexxa), 1 mg

Drug products managed under pharmacy benefitmixed

Brand colchicine	Brand colchicine products (e.g., Colcrys, Gloperba) managed through pharmacy benefit; may be considered medically necessary when individual tried generic oral colchicine or generic oral allopurinol first and had an inadequate response.
Uloric	Febuxostat managed through pharmacy benefit; may be considered when tried and serum uric acid remains > 6 mg/dL or per policy criteria.
Zyloprim	Allopurinol managed through pharmacy benefit; prior trial required before some brand colchicine products; consider HLA-B*5801 testing and contraindications to allopurinol.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization and benefit routing

Prior authorization is required. Krystexxa (pegloticase) is managed as a medical benefit. Ilaris (canakinumab) is managed under both pharmacy and medical benefits depending on site of service. Brand colchicine, Uloric (febuxostat), and Zyloprim (allopurinol) are managed through the pharmacy benefit. Non-formulary exception reviews may be approved for up to 12 months.

Krystexxa (pegloticase) = Medical benefit
Ilaris (canakinumab) = Managed via pharmacy and medical benefit depending on administration/site of service
Brand colchicine, Uloric (febuxostat), Zyloprim (allopurinol) = Pharmacy benefit
Non-formulary exception reviews may be approved up to 12 months

Documentation Required

Medical record documentation

Background & Evidence

Gout is inflammatory arthritis caused by deposition of monosodium urate crystals resulting from hyperuricemia. Urate supersaturates and crystals form at increased concentrations (> 6.8 mg/dL), promoting nucleation and crystal growth and triggering intense inflammatory responses mediated by IL‑1β and neutrophilic synovitis.

Hyperuricemia is most commonly due to inefficient renal excretion (~90%) or, less commonly, uric acid overproduction (~10%). Risk factors include increasing age, obesity, diuretic use, hypertension, type II diabetes, renal disease (including severe renal dysfunction), high-purine diet, heavy alcohol intake, and fructose consumption.

Urate homeostasis depends on renal and gut excretion (≈70% renal, ≈30% gut) with URAT1-mediated proximal tubular reabsorption; factors such as insulin resistance, drug effects, and reduced GFR increase urate retention and gout risk.

Urate-lowering therapy is used to prevent future attacks, reduce tophi and organ deposition, and achieve and maintain sUA below the treatment target. Policy use of sUA thresholds: persistent sUA > 6 mg/dL during therapy denotes inadequate response (e.g., prior-to-Krystexxa requirement) and documented sUA < 6 mg/dL is required to demonstrate continued positive clinical response for re-authorization.

Clinical trial and policy language support treating to sUA <6 mg/dL (clinical response marker) and recognize sUA >6.8 mg/dL as the concentration above which crystal formation is more likely.

Study/Label	Key findings
Krystexxa + methotrexate trial (NCT03994731)
Month 6 responder rates: 71% for Krystexxa+MTX vs 39% for Krystexxa alone (p<0.0001); Month 12: 60% vs 31% (p=0.0003)
Tophi response (co-admin with MTX)
Complete tophi response at Month 12: 54% (Krystexxa+MTX) vs 31% (Krystexxa alone)

Site of Service (SOS): The location where a drug is administered (hospital-based outpatient, infusion center, physician's office, or at home). The policy applies SOS review to IV/injectable drugs and limits site-of-service review to individuals aged >= 13 years for SOS determinations.

Chronic gout: Defined as when a person has 2 or more gout attacks in a year.

Revision History

2026-03-01revisedLatest

Removed coverage criteria for Mitigare (colchicine); references updated.

2025-10-03revised

Added site of service review to Ilaris (canakinumab) and clarified that Site of Service (SOS) Medical Necessity criteria can apply to injection drugs.

2024-03-01revised

Added coverage criteria for Ilaris (canakinumab) for treatment of acute gout flares, including requirement for prior intolerance/contraindication to NSAIDs/colchicine, corticosteroid retreatment limitations, and dose limit of 150 mg every 12 weeks.

Policy Summary

PayerPremera Bluecross

PolicyPHARMACOLOGIC TREATMENT OF GOUT

Policy CodePolicy N/A

Change TypeRemoved Mitigare; added/updated Ilaris, Krystexxa, Colcrys criteria

Effective DateMar 1, 2026

Next Review Date

Key ActionSubmit office visit notes documenting diagnosis, relevant history, physical evaluation, G6PD status, and medication history to demonstrate medical necessity.

On This Page

Hospital-based outpatient setting may be medically necessary when ANY of the following are met

No local outpatient/home infusion: No outpatient infusion center within 50 miles of individual's home and no contracted home infusion agency will travel to their home (or hospital only place offering the drug)
Clinical condition increasing infusion risk: Individual has a clinical condition increasing risk of complications for infusion/injection, including known cardiac condition (e.g., symptomatic cardiac arrhythmia) or pulmonary condition (e.g., significant respiratory disease, serious obstructive airway disease, %FVC <= 40%)%FVC <= 40%
Unstable renal function which decreases ability to respond to fluids
Difficult vascular access: Difficult or unstable vascular access
Cognitive safety concern: Acute mental status changes or cognitive conditions that impact safety of infusion/injection therapy
History of severe reactions: Known history of severe adverse drug reactions and/or anaphylaxis to prior treatment with a related or similar drug

CRS criteria for hospital setting

CRS - fever: Temperature at least 38 °C>= 38 °C
CRS - hypotension: Hypotension that requires 1 or more vasopressorsrequires >=1 vasopressors
CRS - hypoxia: Hypoxia that requires oxygen through high-flow nasal cannula, face mask, non-rebreather mask, or Venturi mask OR positive pressure (CPAP, BiPAP, intubation, or mechanical ventilation)
CRS - inpatient admission: Individual will be admitted into an inpatient setting as soon as criteria are met

Example drug listed for SOS review: Ilaris (canakinumab) is listed as a drug subject to site of service review

Ilaris (canakinumab) - acute gout flares

Ilaris SC may be considered medically necessary for acute gout flares when ALL of the following are met:

Ilaris - acute gout flares criteria

Age: Individual is aged 18 years or older>= 18 years
NSAID/colchicine failure: Has intolerance, contraindication, or lack of response to NSAIDs and colchicine for acute gout flares
Corticosteroid history: Has been previously treated with oral or injectable corticosteroids and is unable to be retreated with a repeat course of corticosteroids for acute gout flares
Use with ULT: Will be used in combination with a urate lowering medication (e.g., allopurinol, febuxostat, or probenecid) unless contraindicated
Dose limited to 150 mg every 12 weeks150 mg every 12 weeks
Dose limit explicitly stated in policy
Prescriber: Medication prescribed by or in consultation with a rheumatologist

Krystexxa (pegloticase) IV - chronic gout

Krystexxa may be considered medically necessary for chronic gout when ALL of the following are met:

Krystexxa - chronic gout criteria

Age: Individual is aged 18 years or older>= 18 years
Prior allopurinol requirement (ONE of)
- Inadequate response to allopurinol: Inadequate response after 3 months of treatment at the maximum tolerated dose with serum uric acid remaining > 6 mg/dL> 6 mg/dL
- Allopurinol intolerance: Intolerance to use of allopurinol
- Allopurinol contraindication or HLA-B*5801: Contraindication to use of allopurinol or tested positive for HLA-B*5801 allele
Other ULT trial and sUA: Has tried one of the following urate-lowering therapies unless clinical reason provided why not able to take: febuxostat OR probenecid; and serum uric acid levels remain > 6 mg/dL> 6 mg/dL
G6PD status: Documentation provided that individual does NOT have G6PD deficiency (contraindication to Krystexxa)G6PD negative
Dosing: Krystexxa administered as an 8 mg infusion every two weeks8 mg every 2 weeks
Methotrexate co-administration: Krystexxa is co-administered with oral methotrexate 15 mg weekly unless methotrexate is contraindicated or not clinically appropriateMTX 15 mg weekly
Prescriber: Medication prescribed by or in consultation with a rheumatologist

Brand colchicine, Colcrys, Gloperba, Uloric (febuxostat), Zyloprim (allopurinol)

May be considered medically necessary when ALL of the following are met:

Brand colchicine and select gout drugs criteria

Trial requirement: Individual tried generic oral colchicine or generic oral allopurinol first and had an inadequate response

Investigational/Not covered

Other uses

Investigational/Not covered: All other uses of the drugs listed in this policy that are not outlined are considered investigational

ref

Re-authorization criteria

Conditions for continued approval:

Continuation of drug-specific criteria: Drug-specific coverage criteria continue to be met
Documented response: Chart notes demonstrate continued positive clinical response to therapy, e.g., documented serum uric acid < 6 mg/dLsUA < 6 mg/dL

Document in the medical record the office visit notes including the diagnosis, relevant history, results of the physical examination, G6PD status, and a complete medication history. Include notes supporting medical necessity, prior treatments tried, intolerances or contraindications, and any specialist consultation (e.g., rheumatologist) when applicable.

Required: office visit notes with diagnosis, history, physical exam
Required: G6PD status documented
Required: complete medication history and prior treatment responses
Include specialist consultation notes when applicable (e.g., rheumatologist)

Documentation Required

G6PD screening for Krystexxa

For Krystexxa (pegloticase), document a negative G6PD test result in the medical record prior to administration. G6PD deficiency is a contraindication to Krystexxa and must be ruled out.

Document G6PD negative result prior to Krystexxa initiation
If G6PD status is unknown, testing must be completed and documented before dosing

Documentation Required

HLA-B*5801 consideration

When allopurinol is being considered, document HLA-B*5801 testing results if relevant (e.g., individuals of higher-risk ethnicities) or document a clear contraindication to allopurinol when applicable.

Document HLA-B*5801 test results when relevant (e.g., Asian ethnicities) OR
Document contraindication to allopurinol if testing not performed

Documentation Required

Methotrexate co-administration for Krystexxa

When initiating Krystexxa (pegloticase), document co-administration of oral methotrexate 15 mg weekly unless methotrexate is contraindicated or not clinically appropriate. If methotrexate cannot be used, document the clinical rationale and any alternative immunomodulatory strategy.

Krystexxa should be co-administered with oral methotrexate 15 mg weekly unless contraindicated
If methotrexate is contraindicated, document the contraindication and clinical rationale for not using methotrexate
Document monitoring plan and any alternative co-therapy when methotrexate is not used

2022-12-01revised

Added requirement that Krystexxa (pegloticase) be co‑administered with oral methotrexate 15 mg weekly unless methotrexate is contraindicated or not clinically appropriate.

2025-02-01clarified

Administrative move: several gout drugs (brand colchicine, Gloperba, Mitigare, Uloric, Zyloprim) were moved into this policy from a different policy with no changes to coverage criteria.

2025-10-03revised

Added Colcrys (colchicine) to the list of gout drugs that require prior trial of generic oral colchicine or generic oral allopurinol.